2ONE Labs Receives PMTA 'Acceptance' for 2ONE® Nicotine Pouch brand from FDA Center for To
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LAKE TAHOE, Nev., Oct. 29, 2024 (GLOBE NEWSWIRE) - 2ONE Labs Inc., is pleased to announce the 'Acceptance' of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Ad...
LAKE TAHOE, Nev., Oct. 29, 2024 (GLOBE NEWSWIRE) - 2ONE Labs Inc., is pleased to announce the 'Acceptance' of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Administration for its 2ONE® branded nicotine pouches.
Acknowledging receipt of the FDA ‘Acceptance’ notification, Vincent Schuman, CEO of 2ONE Labs, said: “This means the 2ONE® PMTA application will now move forward to the next important stage of FDA review. Our company will continue to fully fund this submission to a successful conclusion, and our wholesale, retail and sponsorship partners should take confidence in this ‘Acceptance’ as a sign of our ability to navigate this complex PMTA process, and of our unwavering commitment to support the long-term availability of the 2ONE® brand in the US market.”
Schuman added: “We created 2ONE® nicotine pouches for adult users (21+), who find it challenging to switch from combustible or traditional oral tobacco-leaf products. The availability of the 2ONE® brand in the market over the past 5 years, and the interest and growth our brand has achieved through strong retail partnerships, such as with CircleK®, has shown it is possible - even for innovative companies - to identify and introduce unique brands that truly offer adults the perfect switching product. We are encouraged by FDA’s acceptance of the 2ONE® PMTA submission and we look forward to continuing to support the needs of adult consumers switching from tobacco.”
2ONE® nicotine pouch products are offered in a variety of nicotine levels and satisfying flavors at over 18,000 retail outlets nationwide, and can be purchased online by adult consumers at: 21Pouches.com.
About 2ONE® Nicotine Pouches
2ONE Labs Inc.: Founded by pioneers in synthetic nicotine production, 2ONE Labs specializes in providing the most innovative tobacco-free nicotine products to adult consumers seeking an alternative to other tobacco products. For more information, contact 21Pouches.com. 2ONE® is a registered trademark of 2ONE Labs Inc., Lake Tahoe, NV. All Rights Reserved.
Source: 2ONE LABS INC.
Contact:
Vincent@21pouches.com
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